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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA COLONOSCOPE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA COLONOSCOPE Back to Search Results
Model Number EC34-I10CL
Medical Device Problem Codes Poor Quality Image (1408); Optical Distortion (3000)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model ec34-i10cl-us is available in the usa with a 510k number k190805.Evaluation summary it was caused due to a fluid damage in the endoscope through the perforated bending rubber.Repair replaced bending rubber.This report is being filed as part of the pentax backlog management plan.
 
Event or Problem Description
Poor quality image-black dots on image.The time of event is unknown.There was no report of patient harm.
 
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Brand Name
PENTAX
Common Device Name
IMAGINA COLONOSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12171257
Report Number9610877-2021-10598
Device Sequence Number10990295
Product Code FDF
UDI-Device Identifier04961333248711
UDI-Public04961333248711
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberEC34-I10CL
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/05/2021
Initial Report FDA Received Date07/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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